Trial · NCT00105534
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
NCT00105534, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2011-10-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003). Trials, record NCT00105534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00105534
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
- NCT number
- NCT00105534
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 685 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Bacterial Conjunctivitis
- Interventions
- AzaSite, Vehicle
- First posted
- 2005-03-16
- Last updated
- 2013-11-21
- Results first posted
- 2011-10-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Who Achieved Clinical Resolution | Visit 3 (Days 6-7) | Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. |
| Secondary | Participants Who Achieved Bacteriological Eradication | Visit 3 (Day 6-7) | Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Who Achieved Clinical Resolution | Visit 3 (Days 6-7) | Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward. | Participants | NUMBER |
| SECONDARY | Participants Who Achieved Bacteriological Eradication | Visit 3 (Day 6-7) | Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Who Achieved Clinical Resolution | AzaSite | 82 | Participants | ||
| Participants Who Achieved Clinical Resolution | Vehicle | 74 | Participants | ||
| Participants Who Achieved Bacteriological Eradication | AzaSite | 115 | Participants | ||
| Participants Who Achieved Bacteriological Eradication | Vehicle | 99 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AzaSite | 335 | |
| Overall Study | STARTED | Vehicle | 350 | |
| Overall Study | COMPLETED | AzaSite | 313 | |
| Overall Study | COMPLETED | Vehicle | 317 | |
| Overall Study | NOT COMPLETED | AzaSite | 22 | |
| Overall Study | NOT COMPLETED | Vehicle | 33 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cornela Ulcer | Eye disorders | AzaSite | 0 | 333 | 0 |
| serious | Cornela Ulcer | Eye disorders | Vehicle | 1 | 350 | 1 |
| serious | Cerebrovascular Accident | Nervous system disorders | AzaSite | 0 | 333 | 0 |
| serious | Cerebrovascular Accident | Nervous system disorders | Vehicle | 1 | 350 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AzaSite | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | AzaSite | 0 | 333 |
| Total, other adverse events | Vehicle | 0 | 350 |
| Total, serious adverse events | AzaSite | 0 | 333 |
| Total, serious adverse events | Vehicle | 2 | 350 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18374301 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AzaSite vs Vehicle: Participants Who Achieved Bacteriological Eradication | Trial comparisons |
| AzaSite vs Vehicle: Participants Who Achieved Clinical Resolution | Trial comparisons |
| AzaSite vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00105534
GET https://conductscience.org/api/trials/v1/NCT00105534/registered